MAUDE Adverse Event Report: ABBOTT MEDICAL TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-21A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Aneurysm (1708); Aortic Valve Stenosis (1717)

Event Date 05/18/2022

Event Type  Injury  

Event Description

It was reported that a 21 mm trifecta valve was implanted on (b)(6) 2017.Approximately 12 months ago, rapidly progressive structural valve deterioration was observed with symptoms of severe aortic stenosis, high gradient, dyspnea, angina, and pre-syncope.On (b)(6) 2022 the device was explanted and replaced with 21mm regent mechanical valve.Upon explant, there was no interaction between any stent post and patient anatomy.The device was found to have pannus on the sewing cuff ( aortic and ventricular side) extending onto leaflets; calcified leaflets with no aortic regurgitation was observed.The patient was reported to be in stable condition.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Explant due to structural valve deterioration with symptoms of severe aortic stenosis was reported.The investigation confirmed calcification on all three leaflets.There was fibrous thickening on all leaflets.Leaflet 1 was torn at the top of stent post 1.Leaflet 2 contained a tear/incision with missing tissue.There was circumferential fibrous pannus ingrowth on the inflow surface.No inflammation was present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Calcification is a known potential adverse event associated with bioprosthetic heart valves.Per the warnings section of the instructions for use "accelerated deterioration due to calcific degeneration of the valve may occur in:" "children, adolescents, or young adults", "patients with altered calcium metabolism (e.G., patients with hyperparathyroidism or chronic renal failure)" or "individuals requiring hemodialysis".The limited mobility of the leaflets and tears associated with calcifications, further exacerbated by the pannus ingrowth, is consistent with the insufficiency and elevated gradient noted prior to explant.

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14704508
• MDR Text Key: 294903181
• Report Number: 2135147-2022-00390
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2019
• Device Model Number: TF-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 5845259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female